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COMPLIED STANDARDS
EMC GUIDANCE
EMC GUIDANCE
FCC STATEMENT
Risk Management
ISO 14971:2012 Medical devices — Application of risk
management to medical devices.
Labeling
ISO 15223-1:2012 Medical devices. Symbols to be used with
medical device labels, labeling and information to be supplied.
General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide
information
General Requirements
for Safety
IEC 60601-1: 2005+A1:2012 Medical electrical equipment
- Part 1: General requirements for basic safety and essential
performance
Electromagnetic compatibility
IEC 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance and clinical
requirements
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated
Software life-cycle processes
IEC 62304:2006+AC: 2008 Medical device software - Software
life cycle processes
Table 1
Guidance and Manufacturer’s declaration – ELECTROMAGNETIC EMISSIONS -
for all ME EQUIPMENT and ME SYSTEMS
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received,
including interference that may cause undesired
operation.
Table 6
Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration - electromagnetic emission
The device is intended for use in the electromagnetic environment specied below. The
customer or the user of the device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF Emissions - CISPR 11 Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions - CISPR 11 Class B
Harmonic emissions -
IEC 61000-3-2
Not
Applicable
Voltage Fluctuations / Flicker
Emissions IEC 61000-3-3
Not
Applicable
Recommended separation distances between portable and mobile RF communications
equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the device as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 Not Applicable 0.117 0.233
0.1 Not Applicable 0.369 0.738
1 Not Applicable 1.167 2.333
10 Not Applicable 3.690 7.378
100 Not Applicable 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reection from structures, objects and people.
P
V
=d ]
5,3
[
1
P=d 1.167
2.333 P=d
25 26
15


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